Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05837091 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Low Sodium Oxybate in Patients With Idiopathic Hypersomnia

StatusRecruiting
PhasePhase 4
Started2024-02-14
View on ClinicalTrials.gov ↗

Amendment history

2026-05-08
Study Status v15
Primary completion date2026-01-29→2027-01-29
Completion date2026-06→2027-06
2025-07-10
Study Status v14
Primary completion date2025-06→2026-01-29
Completion date2025-06→2026-06
2025-04-14
Study Identification, Study Status, Contacts/Locations v13
Study sitescontacts updated at 4 of 4 sites
Study titlerevised
Low Sodium Oxybate in Patients withWith Idiopathic Hypersomnia
2025-02-28
Study Identification, Study Status, Contacts/Locations v12
Study sitescontacts updated at 4 of 4 sites
Study titlerevised
Low Sodium Oxybate in Patients Withwith Idiopathic Hypersomnia
2024-09-21
Study Status, Contacts/Locations, References v11
Study sitesdetails revised at 1 of 4 sites
Show 10 earlier versions
2024-04-08
Study Status, Contacts/Locations v10
Study sitescontacts updated at 1 of 4 sites
2024-03-16
Study Status, Eligibility v9
Eligibility criteria-1 characters
[...] BMI between 18 and 35 kg/m2 Self-reported sleep duration ≥ 109 hours most days including daytime naps/sleep based upon at [...]
2024-02-15
Study Status, Contacts/Locations v8
Start dateestimated 2024-03→confirmed 2024-02-14
Study sitescontacts updated at 2 of 4 sites
2024-01-24
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 4 sites
2024-01-15
Study Status, Contacts/Locations v6
Start date2023-12→2024-03
Study sitesdetails revised at 1 of 4 sites
2023-12-05
Study Status v5
Start date2023-10→2023-12
2023-10-02
Study Status v4
Start date2023-09→2023-10
2023-09-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 4 of 4 sites
2023-08-03
Study Status, Outcome Measures, Eligibility v2
Eligibility criteria+300 characters
Inclusion Criteria: Primary diagnosis of IH, according to ICSD-3 criteria (does not require MSLT) Subjects aged 18 - 65 years BMI between 18 and 35 kg/m2 Self-reported sleep duration ≥ 1 [...] eted sleep diary entries Epworth Sleepiness Scale (ESS) ≥ 10 (required at pre-screening visit only) Recommended LSO by a clinical sleep specialist as part of r [...] dy period, and for 30 days after the last dose of study drug. Exclusion Criteria: Succinic semialdehyde dehydrogenase def [...] central nervous system diseases: neurodegenerative diseases, , seizure disorders or history of head trauma associated wit [...] history of s [...]
Secondary endpoints2 to 3 entries
Change in total sleep time as measured by patient sleep diary
2023-08-01
Study Status v1
Start date2023-06→2023-09
2023-04-19
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia. In this study, the researchers want to learn how low sodium oxybate impacts ability of people diagnosed with idiopathic hypersomnia to sleep for long periods of time. In addition, this study will use novel tools to determine when an individual is awake or asleep.
Trial Details
NCT Number NCT05837091
Lead Sponsor Mayo Clinic
Conditions Idiopathic Hypersomnia
Enrollment 30 participants
Start Date 2024-02-14
Primary Completion 2027-01-29 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-12